Multiple pump system for inflatable penile prosthesis

ABSTRACT

According to an aspect, an inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and a pump assembly configured to transfer the fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes a first pump configured to inject the fluid into the inflatable member according to a first flow rate, and a second pump configured to inject fluid into the inflatable member according to a second flow rate, where the second flow rate is less than the first flow rate.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Nonprovisional of, and claims priority to, U.S.Patent Application No. 62/671,583, filed on May 15, 2018, entitled“MULTIPLE PUMP SYSTEM FOR INFLATABLE PENILE PROSTHESIS”, which isincorporated by reference herein in its entirety.

TECHNICAL FIELD

This disclosure relates generally to bodily implants and morespecifically to bodily implants, such as penile prosthesis that includesa multiple pump system.

BACKGROUND

One treatment for male erectile dysfunction is the implantation of apenile prosthesis that mechanically erects the penis. Some existingpenile prostheses include inflatable cylinders or members that can beinflated or deflated using a pump mechanism. The pump mechanism pullsfluid from a fluid reservoir and then transfers the fluid to theinflatable members. According to some existing designs of inflatablepenile prostheses, the amount of time, energy and disparity from theoccurrence of a normal human male erection for the patient to inflate apenile prosthesis (e.g., the number of pumps and time required toprovide the desired penis rigidity) may be relatively high.

SUMMARY

According to an aspect, an inflatable penile prosthesis includes a fluidreservoir configured to hold fluid, an inflatable member, and a pumpassembly configured to transfer the fluid from the fluid reservoir tothe inflatable member during an inflation cycle. The pump assemblyincludes a first pump configured to inject the fluid into the inflatablemember according to a first flow rate, and a second pump configured toinject fluid into the inflatable member according to a second flow rate,where the second flow rate is less than the first flow rate.

According to some aspects, the inflatable penile prosthesis may includeone or more of the following features (or any combination thereof). Thefirst pump may include a plurality of micro-pumps, and the second pumpmay include a plurality of micro-pumps. The first pump is configured toinject the fluid into the inflatable member up to a first maximum outputpressure, and the second pump is configured to inject the fluid into theinflatable member up to a second maximum output pressure, where thesecond maximum output pressure is higher than the first maximum outputpressure. The second pump may be disposed in parallel with the firstpump. The pump assembly is configured to move between a parallelconfiguration in which the second pump is disposed in parallel with thefirst pump and a serial configuration in which the second pump isdisposed in serial with the first pump. The inflatable penile prosthesismay include a controller configured to actuate a plurality of valves tomove between the parallel configuration and the serial configuration.The controller may activate the first pump during a first phase of theinflation cycle, and may activate the second pump during a second phaseof the inflation cycle. The controller may activate the second pumpduring the second phase of the inflation cycle in response to a pressurelevel in the inflatable member exceeding a threshold level. The fluidreservoir may include a flexible fluid container disposed within acavity of the fluid reservoir. The flexible fluid container may enclosefluid at a higher pressure than the fluid contained in the fluidreservoir. At least one of the first pump or the second pump isconfigured to transfer the fluid in the fluid reservoir during a firstphase of the inflation cycle, and the fluid contained in the flexiblefluid container is transferred to the inflatable member during a secondphase of the inflation cycle. The fluid contained in the flexible fluidcontainer may be transferred to the inflatable member after theinflation cycle.

According to an aspect, an inflatable penile prosthesis includes a fluidreservoir configured to hold fluid, an inflatable member, and a pumpassembly configured to transfer the fluid from the fluid reservoir tothe inflatable member during an inflation cycle. The pump assemblyincludes a first pump configured to inject the fluid into the inflatablemember, a second pump configured to inject fluid into the inflatablemember, and a controller configured to activate the first pump during afirst phase of the inflation cycle, and activate at least the secondpump during a second phase of the inflation cycle.

According to some aspects, the inflatable penile prosthesis may includeone or more of the following features (or any combination thereof). Thefirst pump may include a plurality of micro-pumps disposed on a firstsubstrate, and the second pump may include a plurality of micro-pumpsdisposed on a second substrate. A number of the plurality of micro-pumpsdisposed on the first substrate may be less than a number of theplurality of micro-pumps disposed on the second substrate. The firstpump is configured to inject the fluid into the inflatable memberaccording to a first flow rate up to a first maximum output pressure,and the second pump is configured to inject the fluid into theinflatable member according to a second flow rate up to a second maximumoutput pressure, where the first flow rate is higher than the secondflow rate, and the second maximum output pressure is higher than thefirst maximum output pressure. The fluid reservoir may include aflexible fluid container disposed within a cavity of the fluidreservoir, and the flexible fluid container may enclose fluid at ahigher pressure than the fluid contained in the fluid reservoir.

According to an aspect, a method of inflating an inflatable member of apenile prosthesis includes transferring, by a first pump of a pumpassembly, fluid from a fluid reservoir to the inflatable member during afirst phase of an inflation cycle, detecting, by a sensor, a pressurelevel in the inflatable member, activating, by a controller connected tothe sensor, a second pump of the pump assembly in response to thepressure level exceeding a threshold level, and transferring, by atleast the second pump, fluid from the fluid reservoir to the inflatablemember during a second phase of the inflation cycle.

According to some aspects, the method may include one or more of thefollowing features (or any combination thereof). The second pump may bedisposed in parallel with the first pump during the first phase. Thesecond pump may be disposed in parallel with the first pump during thesecond phase. The first pump and the second pump may be disposed in aparallel configuration during the first phase, and the method furtherincludes switching to a serial configuration during the second phase.The serial configuration is a configuration in which the first pump isserially disposed with respect to the second pump.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an inflatable penile prosthesis having a pumpassembly that includes a first pump and a second pump according to anaspect.

FIG. 2A illustrates an example of the first pump of the pump assemblyaccording to an aspect.

FIG. 2B illustrates an example of the second pump of the pump assemblyaccording to an aspect.

FIG. 3 illustrates an inflatable penile prosthesis having a pumpassembly that includes a first pump in parallel with a second pumpaccording to an aspect.

FIG. 4A illustrates an inflatable penile prosthesis having a multiplepump assembly in a first configuration according to an aspect.

FIG. 4B illustrates the inflatable penile prosthesis having the multiplepump assembly in a second configuration according to an aspect.

FIG. 4C illustrates the inflatable penile prosthesis having the multiplepump assembly in a third configuration according to an aspect.

FIG. 4D illustrates the inflatable penile prosthesis having the multiplepump assembly in a fourth configuration according to an aspect.

FIG. 4E illustrates the inflatable penile prosthesis having the multiplepump assembly in a fifth configuration according to an aspect.

FIG. 5A illustrates an inflatable penile prosthesis having a pumpassembly and a flexible fluid container in a first configurationaccording to an aspect.

FIG. 5B illustrates the inflatable penile prosthesis having the pumpassembly and the flexible fluid container in a second configurationaccording to an aspect.

FIG. 5C illustrates the inflatable penile prosthesis having the pumpassembly and the flexible fluid container in a third configurationaccording to an aspect.

FIG. 6 illustrates an inflatable penile prosthesis having the multiplepump assembly according to an aspect.

FIG. 7 illustrates a flow chart depicting example operations of a pumpassembly according to an aspect.

DETAILED DESCRIPTION

Detailed embodiments are disclosed herein. However, it is understoodthat the disclosed embodiments are merely examples, which may beembodied in various forms. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a basis for the claims and as a representative basis forteaching one skilled in the art to variously employ the embodiments invirtually any appropriately detailed structure. Further, the terms andphrases used herein are not intended to be limiting, but to provide anunderstandable description of the present disclosure.

The terms “a” or “an,” as used herein, are defined as one or more thanone. The term “another,” as used herein, is defined as at least a secondor more. The terms “including” and/or “having”, as used herein, aredefined as comprising (i.e., open transition). The term “coupled” or“moveably coupled,” as used herein, is defined as connected, althoughnot necessarily directly and mechanically.

In general, the embodiments are directed to bodily implants. The termpatient or user may hereafter be used for a person who benefits from themedical device or the methods disclosed in the present disclosure. Forexample, the patient can be a person whose body is implanted with themedical device or the method disclosed for operating the medical deviceby the present disclosure. For example, in some embodiments, the patientmay be a human, or any other mammal.

FIG. 1 illustrates an inflatable penile prosthesis 100 having a multiplepump system that can improve an inflation operation of the prosthesis'sinflatable member according to an aspect. The inflatable penileprosthesis 100 may include a fluid reservoir 102, an inflatable member104, and a pump assembly 106 configured to transfer fluid between thefluid reservoir 102 and the inflatable member 104. The inflatable member104 may be implanted into the corpus cavernosae of the user, the fluidreservoir 102 may be implanted in the abdomen or pelvic cavity of theuser (e.g., the fluid reservoir 102 may be implanted in the lowerportion of the user's abdominal cavity or the upper portion of theuser's pelvic cavity), and the pump assembly 106 may be implanted in thescrotum of the user.

The pump assembly 106 includes multiple pumps that pump fluid into theinflatable member 104 during an inflation cycle in a manner thatincreases the efficiency and/or decreases the amount of time required tofully inflate the inflatable member 104. In some examples, the multiplepumps operate at different time periods during the inflation cycle. Insome examples, the multiple pumps operate at a same time during at leasta portion of the inflation cycle. In some examples, the multiple pumpsare not individually controlled by the user, but are mechanically and/orprogrammatically controlled by a controller 112, which from the point ofview of the user, the multiple pumps of the pump assembly 106 may appearas a single pump. In some examples, the user is able to program themaximum output pressure and/or the pressure profile during intercourse.For example, the rigidity of the penile implant may be controlled suchthat preliminary ejaculation may be avoided.

The inflatable member 104 may be capable of expanding upon the injectionof fluid into a cavity of the inflatable member 104. For instance, uponinjection of the fluid into the inflatable member 104, the inflatablemember 104 may increase its length and/or width, as well as increase itsrigidity. In some examples, the inflatable member 104 may include a pairof inflatable cylinders or at least two cylinders, e.g., a firstcylinder member and a second cylinder member. The volumetric capacity ofthe inflatable member 104 may depend on the size of the inflatablecylinders. In some examples, the volume of fluid in each cylinder mayvary from about 10 milliliters in smaller cylinders and to about 50milliliters in larger sizes. In some examples, the first cylinder membermay be larger than the second cylinder member. In other examples, thefirst cylinder member may have the same size as the second cylindermember.

The fluid reservoir 102 may include a container having an internalchamber configured to hold or house fluid that is used to inflate theinflatable member 104. The volumetric capacity of the fluid reservoir102 may vary depending on the size of the inflatable penile prosthesis100. In some examples, the volumetric capacity of the fluid reservoir102 may be 3 to 150 cubic centimeters. In some examples, the fluidreservoir 102 is constructed from the same material as the inflatablemember 104. In other examples, the fluid reservoir 102 is constructedfrom a different material than the inflatable member 104. In someexamples, the fluid reservoir 102 contains a larger volume of fluid thanthe inflatable member 104.

The inflatable penile prosthesis 100 may include a first conduitconnector 103 and a second conduit connector 105. Each of the firstconduit connector 103 and the second conduit connector 105 may define alumen configured to transfer the fluid to and from the pump assembly106. The first conduit connector 103 may be coupled to the pump assembly106 and the fluid reservoir 102 such that fluid can be transferredbetween the pump assembly 106 and the fluid reservoir 102 via the firstconduit connector 103. For example, the first conduit connector 103 maydefine a first lumen configured to transfer fluid between the pumpassembly 106 and the fluid reservoir 102. The first conduit connector103 may include a single or multiple tube members for transferring thefluid between the pump assembly 106 and the fluid reservoir 102.

The second conduit connector 105 may be coupled to the pump assembly 106and the inflatable member 104 such that fluid can be transferred betweenthe pump assembly 106 and the inflatable member 104 via the secondconduit connector 105. For example, the second conduit connector 105 maydefine a second lumen configured to transfer fluid between the pumpassembly 106 and the inflatable member 104. The second conduit connector105 may include a single or multiple tube members for transferring thefluid between the pump assembly 106 and the inflatable member 104. Insome examples, the first conduit connector 103 and the second conduitconnector 105 may include a silicone rubber material. In some examples,the pump assembly 106 may be directly connected to the fluid reservoir102.

The pump assembly 106 includes a first pump 108, a second pump 110, thecontroller 112, a sensor 115, and a power source 114. The pump assembly106 may include other features such as a valve body, a pump bulb, one ormore valves, and/or an inflation mode selector configured to selectbetween an inflation mode and a deflation mode. In some examples, thepump assembly 106 includes more than two pumps such as three pumps ormore than three pumps, which can be arranged in a parallel configurationand/or a serial configuration with respect to each (and may transitionbetween the parallel configuration and the serial configuration duringdifferent phases of the inflation cycle).

The first pump 108 is configured to facilitate the transfer of fluidfrom the fluid reservoir 102 to the inflatable member 104 according to afirst flow rate up to a first maximum output pressure. The second pump110 is configured to facilitate transfer of fluid from the fluidreservoir 102 to the inflatable member 104 according to a second flowrate up to a second maximum output pressure. In some examples, the firstflow rate is higher than the second flow rate. In some examples, thefirst maximum output pressure is lower than the second maximum outputpressure. In some examples, the first pump 108 is a high capacity pump(e.g., high flow rate) but with relatively low output pressure. In someexamples, the second pump 110 is a low capacity pump (e.g., low flowrate) but with relatively high output pressure.

The first pump 108 may include one or more devices configured tofacilitate the transfer of fluid from the fluid reservoir 102 to theinflatable member 104. In some examples, referring to FIG. 2A, the firstpump 108 includes micro-pumps 220 disposed on a first substrate 222,which are arranged to provide the first flow rate and the first maximumoutput pressure. In some examples, the micro-pumps 220 arepiezoelectrically-driven micro-pumps. In some examples, the micro-pumps220 include a first dimension in a range of 4 mm to 15 mm, a seconddimension in a range of 4 mm to 15 mm, and/or a third dimension in arange of 0.4 mm to 2 mm. In some examples, the micro-pumps 220 include asilicon-based material. In some examples, the micro-pumps 220 includes ametal (e.g., steel) based material. In some examples, the firstsubstrate 222 includes a wafer. Although FIG. 2A illustrates fourmicro-pumps 220, the embodiments encompass any number of micro-pumps 220disposed on the first substrate 222 including one micro-pump or morethan one micro-pump. In some examples, the first pump 108 includes morethan ten micro-pumps 220 arranged on the first substrate 222. In someexamples, the first pump 108 includes more than twenty micro-pumps 220arranged on the first substrate 222. In some examples, the first pump108 includes more than forty micro-pumps 220 arranged on the firstsubstrate 222. In some examples, the micro-pumps 220 disposed on thefirst substrate 222 are non-mechanical (e.g., without moving parts).

The second pump 110 may include one or more devices configured tofacilitate the transfer of fluid from the fluid reservoir 102 to theinflatable member 104. In some examples, referring to FIG. 2B, thesecond pump 110 includes micro-pumps 220 disposed on a second substrate225, which are arranged to provide the second flow rate and the secondmaximum output pressure. In some examples, the first substrate 222 andthe second substrate 225 are the same substrate (e.g., the micro-pumps220 for the first pump 108 and the micro-pumps 220 for the second pump210 are disposed on the same substrate). In some examples, the firstsubstrate 222 and the second substrate 225 are different substrates.

In some examples, the second substrate 225 includes a wafer. AlthoughFIG. 2B illustrates two micro-pumps 220 disposed on the second substrate225, the embodiments encompass any number of micro-pumps 220 includingone micro-pump or more than one micro-pump on the second substrate 225.In some examples, the second pump 110 includes more micro-pumps 220 thanthe first pump 108. In some examples, the second pump 110 includes lessmicro-pumps 220 than the first pump 108. In some examples, the secondpump 110 includes two or more micro-pumps 220 arranged on the secondsubstrate 225. In some examples, the second pump 110 includes more thanten micro-pumps 220 arranged on the second substrate 225. In someexamples, the second pump 110 includes more than twenty micro-pumps 220arranged on the second substrate 225. In some examples, the micro-pumps220 disposed on the second substrate 225 are non-mechanical (e.g.,without moving parts).

In some examples, the first pump 108 and the second pump 110 arearranged in a parallel configuration during an inflation cycle. In someexamples, the first pump 108 and the second pump 110 are arranged in theparallel configuration during the entire inflation cycle. In someexamples, the first pump 108 and the second pump 110 are arranged in theparallel configuration for only a portion of the inflation cycle. In theparallel configuration, each of the first pump 108 and the second pump110 are configured to receive fluid from the fluid reservoir 102, andinject the fluid into the inflatable member 104 during the inflationcycle. In some examples, the first pump 108 is configured to fill theinflatable member 104 at the first flow rate up to the first maximumoutput pressure (e.g., higher flow rate, lower output pressure) during afirst phase of the inflation cycle until the pressure level in theinflatable member 104 reaches a threshold level. In some examples, thethreshold level is in relation to the total volume of the inflatablemember 104. In some examples, the threshold level is in relation to thetotal amount of pressure in the inflatable member 104. Upon reaching thethreshold level, the pump assembly 106 may activate (or switch to) tothe second pump 110, and the second pump 110 injects the remainingamount of fluid at the second flow rate up to the second maximum outputpressure (e.g., lower flow rate, higher output pressure). In someexamples, the controller 112 may de-activate the first pump 108 duringthe second phase (e.g., after the second phase starts but before thesecond phase ends).

The sensor 115 is configured to monitor the pressure level in theinflatable member 104. In some examples, the sensor 115 is calibratedbefore the inflation and deflation cycle is commenced. The sensor 115 iscommunicatively coupled to the controller 112 such that the controller112 can receive signals from the sensor 115. In some examples, thesensor 115 is included within the pump assembly 106. In some examples,the sensor 115 is configured to sense the amount of fluid transferred tothe inflatable member 104, and send one or more signals to thecontroller 112 that indicate the amount of fluid that has beentransferred.

In some examples, the sensor 115 is included within the inflatablemember 104. In some examples, the sensor 115 is integrated in a wall ofa cylinder of the inflatable member 104. In some example, when thesensor 115 is integrated in the wall of the cylinder, the sensor 115 maymonitor the condition of the cylinder material, and the sensor 115 canmonitor the changing of the cylinder material to a point where thecylinder might have to be replaced. In this case, the controller 112 maysend information, over a network, to an external device (e.g., locatedat a hospital or doctor's office) on a regular basis for potentialcheckups.

In some examples, the sensor 115 is configured to sense the pressurelevel in the inflatable member 104 and send one or more signals to thecontroller 112 that indicate the pressure level in the inflatable member104. In some examples, the sensor 115 is configured to monitor theflowrate (e.g., the flowrate in both directions). The controller 112 maycontrol the activation (and deactivation) of the first pump 108 and thesecond pump 110 based on the signals received from the sensor 115 suchthat the operator is unaware of that the pump assembly 106 includesmultiple pumps operating at different times. In some examples, thecontroller 112 may send activation signals or deactivation signals tothe first pump 108 and the second pump 110 to controls the activationand deactivation of the first pump 108 and the second pump 110.

During the first phase of the inflation cycle, the controller 112 mayactivate the first pump 108 and deactivate the second pump 110 such thatthe fluid is injected into the inflatable member 104 using the firstpump 108. The controller 112 may monitor the pressure level in theinflatable member 104, and/or the amount of fluid that is transferred bythe pump assembly 106 (or contained in the inflatable member 104) (e.g.,based on the signals received from the sensor 115), and when the levelmeets or exceeds the threshold level, the controller 112 may deactivatethe first pump 108 and activate the second pump 110 such that the secondpump 110 can fill the remaining amount of the inflatable member 104. Insome examples, the threshold level is an amount within the range of 85%to 95% of the total volume of the inflatable member 104. In someexamples, the threshold level is substantially 90% of the total volumeof the inflatable member 104. In some examples, the controller 112 maymonitor the pressure in the inflatable member 104, and when the pressuremeets or exceeds the threshold level, the controller 112 may deactivatethe first pump 108 and activate the second pump 110 such that the secondpump 110 can fill the remaining amount of the inflatable member 104. Insome examples, the threshold level is at 80% to 90% of the maximumoperating pressure level of a fully inflated inflatable member 104.

The power source 114 is configured to provide a power source for thecontroller 112. In some examples, the controller 112 includes at leastone processor (e.g., coupled to a substrate) and a non-transitorycomputer-readable medium storing executable code, that when executed bythe at least one processor, is configured to perform the operations ofthe controller 112 discussed herein. In some examples, the power source114 includes a battery. In some examples, the controller 112 may includeone or more moving parts in order to control open and close valvesassociated with the pump assembly 106.

In some examples, the controller 112 is configured to control one ormore valves to transition the first pump 108 and the second pump 110between a parallel configuration and a serial configuration duringdifferent phases of the inflation cycle. The valves may be disposed influid passageways within a valve body or block of the pump assembly 106.In some examples, during the first phase of the inflation cycle, thefirst pump 108 and the second pump 110 are arranged in the parallelconfiguration. In some examples, the controller 112 is configured toactuate one or more valves (e.g., place the valves in either an openposition where fluid can flow through a valve or a closed position inwhich fluid is blocked) to arrange the first pump 108 and the secondpump 110 in the parallel configuration. In some examples, during thefirst phase of the inflation cycle, both the first pump 108 and thesecond pump 110 are activated to transfer fluid from the fluid reservoir102 to the inflatable member 104. In some examples, only the first pump108 is activated to transfer fluid to the inflatable member 104.

In some examples, the first pump 108 is activated to fill the inflatablemember 104 at the first flow rate up to the first maximum outputpressure until the inflatable member 104 exceeds the threshold level(e.g., an fluid amount detected, or pressure level, or strain of theinflatable member, by the controller 112 exceeding the threshold level).Upon the detection of exceeding the threshold level by the controller112, the controller 112 is configured to actuate one or more valves toarrange the first pump 108 and the second pump 110 in the serialconfiguration. Then, the first pump 108 and the second pump 110 (inseries with one another) are configured to fill the remaining amount ofthe inflatable member 104 during the second phase of the inflationcycle. In some examples, in the serial configuration, the first pump 108is disposed before the second pump 110 such that the second pump 110receives the output of the first pump 108 and the output of the secondpump 110 is transferred to the inflatable member 104. In other examples,in the serial configuration, the second pump 110 is disposed before thefirst pump 108 such that the first pump 108 receives the output of thesecond pump 110, and the output of the second pump 110 is transferred tothe inflatable member 104.

In some examples, the fluid reservoir 102 includes a flexible fluidcontainer 113. For example, the flexible fluid container 113 may be astructure separate from the fluid reservoir 102 but disposed inside thecavity of the fluid reservoir 102. In some examples, the flexible fluidcontainer 113 includes an expandable balloon disposed inside the cavityof the fluid reservoir 102. In some examples, during a preliminaryperiod (e.g., before the start of the inflation cycle), the pumpassembly 106 may displace fluid from the fluid reservoir 102 into theflexible fluid container 113 causing the flexible fluid container 113 toexpand and increase the pressure inside the flexible fluid container113. In some examples, the controller 112 is configured to activate oneor more valves to direct a fluid flow from the fluid reservoir 102 tothe flexible fluid container 113, and the fluid is pumped into theflexible fluid container 113 using the first pump 108 and/or the secondpump 110. In some examples, the controller 112 may activate the secondpump 110 to transfer the fluid from the fluid reservoir 102 into theflexible fluid container 113. The transfer of the fluid into theflexible fluid container 113 may temporarily store energy into the wallof the flexible fluid container 113 which can be used later to inflatethe inflatable member at high pressure. The energy is stored through theelastic expansion of the wall of the flexible fluid container 113.

In some examples, during a first phase of the inflation cycle, the firstpump 108 (and/or the second pump 110) is/are activated to transfer thefluid from the fluid reservoir 102 to the inflatable member 104 untilreaching the threshold level. Then, during a second phase of theinflation cycle, the controller 112 may actuate the valves to define afluid passageway within the pump assembly 106 between the flexible fluidcontainer 113 and the inflatable member 104 such that the remainingamount is transferred from the flexible fluid container 113 to theinflatable member 104 at a relatively high output pressure. For example,upon defining (or opening) the fluid passageway between the flexiblefluid container 113 and the inflatable member 104, the fluidautomatically flows from the high pressure of the flexible fluidcontainer 113 to the lower pressure of the inflatable member 104. Aftertransferring fluid from the flexible container to the inflatable member104, the controller 112 may close the fluid connection between them byclosing the valve.

In some examples, the flexible fluid container 113 is used to transferfluid to the inflatable member at a higher output pressure at aparticular point or phase in the use of the inflatable member 104 (e.g.,at a point in time after the inflation cycle). For example, thecontroller 112 may include a sensor configured to sense a point in timeduring or before the ejaculation period of the user of the inflatablepenile prosthesis 100, and upon sensing that point, the controller 112may actuate one or more valves to establish the fluid passageway fromthe flexible fluid container 113 to the inflatable member 104 (whichresults in the transfer of fluid from the flexible fluid container 113to the inflatable member 104) such that the pressure in the inflatablemember 104 increases during the ejaculation period. In some examples,the sensor may detect the blood pressure, the heart rate, or thebreathing rate of the user.

FIG. 3 illustrates an inflatable penile prosthesis 300 including a pumpassembly 306 that has a first pump 308 and a second pump 310 in aparallel configuration according to an aspect. The pump assembly 306 isconfigured to transfer fluid from a fluid reservoir 302 to a pair ofinflatable cylinders 304 during an inflation cycle. The first pump 308is disposed in parallel with the second pump 310. The fluid reservoir302 may include any of the features described with reference to thefluid reservoir 102 of FIG. 1. The inflatable cylinders 304 may includeany of the features described with reference to the inflatable member104 of FIG. 1. The pump assembly 306 may include any of the featuresdiscussed with reference to FIGS. 1, 2A, and 2B.

The pump assembly 306 may define fluid passageways that arrange thefirst pump 308 and the second pump 310 in parallel with respect to eachother. An input of the first pump 308 is fluidly coupled to the fluidreservoir 302, and an output of the first pump 308 is fluidly coupled tothe inflatable cylinders 304. An output of the second pump 310 isfluidly coupled to the fluid reservoir 302, and an output of the firstpump 308 is fluidly coupled to the inflatable cylinders 304.

In some examples, the first pump 308 is configured to inject fluid intothe inflatable cylinders 304 during a first phase of an inflation cycle,and the second pump 310 is configured to inject fluid into theinflatable cylinders 304 during a second phase of the inflation cycle,where the second phase is after the first phase. In other examples, thefirst pump 308 and the second pump 310 are configured to simultaneouslyinject fluid into the inflatable cylinders 304 during the inflationcycle. In some examples, the first pump 308 is configured to fill theinflatable cylinders 304 at a first flow rate up to a first maximumoutput pressure (e.g., higher flow rate, lower output pressure) duringthe first phase until the inflatable cylinders 304 reach the thresholdlevel. Upon reaching the threshold level, the pump assembly 306 mayactivate the second pump 310 and inject the remaining amount at thelower flow rate but higher output pressure.

In some examples, the pump assembly 306 includes a controller (e.g., thecontroller 112 of FIG. 1) and a sensor (e.g., the sensor 115 of FIG. 1).The controller is configured to monitor the pressure level and/or theamount of fluid transferred to the inflatable cylinders 304 (e.g., basedon the signals received from the sensor), and control the activation anddeactivation of the first pump 308 and the second pump 310 such that theoperator is unaware of that the pump assembly 306 includes multiplepumps. At the start of the inflation cycle, in some examples, thecontroller may activate the first pump 308 and deactivate the secondpump 310 such that the fluid is injected into the inflatable cylinders304 using the first pump 308 during the first phase. In response to thefluid or pressure level meeting or exceeding the threshold level, thecontroller may deactivate the first pump 308 and activate the secondpump 310 so that the second pump 310 can fill the remaining amount ofthe inflatable cylinders 304. In some examples, the threshold level isan amount within the range of 85% to 95% of the total volume of theinflatable cylinders 304. In some examples, the threshold level issubstantially 90% of the total volume of the inflatable cylinders 304.In some examples, the threshold level is at 80% to 90% of the maximumoperating pressure level of a fully inflated inflatable member 104.

FIGS. 4A through 4E illustrate an inflatable penile prosthesis 400including a pump assembly 406 that has a first pump 408 and a secondpump 410 configured to transition between a parallel configuration and aserial configuration according to an aspect. The pump assembly 406 isconfigured to transfer fluid from a fluid reservoir 402 to a pair ofinflatable cylinders 404 during an inflation cycle. The fluid reservoir402 may include any of the features described with reference to thefluid reservoir 102 of FIG. 1. The inflatable cylinders 404 may includeany of the features described with reference to the inflatable member104 of FIG. 1. The pump assembly 406 may include any of the features ofthe pump assembly (e.g., 106, 306) discussed with reference to FIGS. 1,2A, and 2B.

The pump assembly 406 includes a plurality of valves such as a valve430, a valve 432, and a valve 434, which are disposed within fluidpassageways of the valve block or body of the pump assembly 406. Each ofthe valve 430, the valve 432, and the valve 434 may include a device forcontrolling the passage of fluid through the fluid passageway in whichit is disposed. Each of the valve 430, the valve 432, and the valve 434includes an open position in which fluid is permitted to travel throughthe passageway, and a closed position in which fluid is not permitted totravel through the passageway. Although FIGS. 4A-4E graphicallyrepresent the valves as switches, the open position of the valveindicates that fluid may pass through the valve, and the closed positionof the valve indicates that fluid may be prevented from passing throughthe valve. Also, the pump assembly 406 includes a controller (e.g., thecontroller 112 of FIG. 1) configured to control the actuation (e.g., theopening and closing) of the valve 430, the valve 432, and the valve 434.Each of the valve 430, the valve 432, and the valve 434 includes a firstport and a second port. In the closed position, fluid does not transferbetween the first port and the second port. In the open position, fluidis permitted to transfer between the first port and the second.

An input of the first pump 408 may be fluidly coupled to the fluidreservoir 402, and an input of the second pump 410 may be selectivelycoupled to the fluid reservoir 402 (via the valve 430). An output of thefirst pump 408 is selectively coupled to the inflatable cylinders 404(via the valve 434), and the output of the first pump 408 is selectivelycoupled to the input of the second pump 410 (via the valve 432). Theoutput of the second pump 410 is fluidly coupled to the inflatablecylinders 404.

As shown in FIG. 4A, during a first phase of an inflation cycle, thefirst pump 408 and the second pump 410 are arranged in the parallelconfiguration. In the parallel configuration, the valve 430 is in theopen position, the valve 432 is in the closed position, and the valve434 is in the open position. In the parallel configuration, the firstpump 408 is disposed in parallel with respect to the second pump 410. Insome examples, the first pump 408 is configured to inject fluid from thefluid reservoir 402 to the inflatable cylinders 404 during the firstphase of the inflation cycle. In some examples, the first pump 408 andthe second pump 410 are configured to inject fluid from the fluidreservoir 402 to the inflatable cylinders 404 during the first phase ofthe inflation cycle.

As shown in FIG. 4B, during a second phase of the inflation cycle, thefirst pump 408 and the second pump 410 are arranged in the seriesconfiguration. In some examples, the controller is configured to controlvalve 430, the valve 432, and the valve 434 to arrange the first pump408 and the second pump 410 in the series configuration. In someexamples, in the series configuration, the valve 430 is in the closedposition, the valve 432 is in the open position, and the valve 434 is inthe closed position. In some examples, during the second phase, thefirst pump 408 is connected to and receives the fluid from the fluidreservoir 402, and the output of the second pump 410 is connected to theinput of the second pump 410. The first pump 408 and the second pump 410are configured to serially pump the fluid from the fluid reservoir 402to the inflatable cylinders 404.

As shown in FIG. 4C, during a third phase (e.g., the hold phase) of theinflation cycle, the valve 430 is in the closed position, the valve 432is in the closed position, and the valve 434 is in the closed position,thereby disconnecting the fluid reservoir 402 from the inflatablecylinders 404. As shown in FIG. 4D, during a fourth phase (e.g., releasephase), the valve 430 is in the open position, the valve 432 is in theopen position, and the valve 434 is in the open position. As shown inFIG. 4E, during a fifth phase (e.g., normal operation), the valve 430 isin the open position, the valve 432 is in the closed position, and thevalve 434 is in the closed position.

FIGS. 5A through 5C illustrate an inflatable penile prosthesis 500according to another aspect. The inflatable penile prosthesis 500includes a pair of inflatable cylinders 504, a flexible fluid container513 disposed inside of a fluid reservoir 502, and a pump assembly 506configured to transfer fluid from the fluid reservoir 502 to theinflatable cylinders 504 during an inflation cycle. The pump assembly506 may include a first pump 508, a second pump 510, a valve 532, and avalve 534. The fluid reservoir 502 may include any of the featuresdescribed with reference to the fluid reservoir 102 of FIG. 1. Theinflatable cylinders 504 may include any of the features described withreference to the inflatable member 104 of FIG. 1. The pump assembly 506may include any of the features of the pump assembly discussed withreference to FIGS. 1, 2A, 2B, and 4. For example, the pump assembly 506may include a controller (e.g., the controller 112) that controls theactivation or deactivation of the first pump 508 and the second pump510, and controls the actuating (e.g., the opening and closing) of thevalve 532 and the valve 534.

In some examples, the flexible fluid container 513 may be pressurizedduring a preliminary phase before the inflation cycle. The flexiblefluid container 513 may include a flexible balloon disposed inside ofthe cavity of the fluid reservoir 502. In response to the injection offluid within the cavity of the flexible fluid container 513, theflexible fluid container 513 may expand causing the pressure to increaseinside of the flexible fluid container 513. As shown in FIG. 5A, duringthe preliminary phase, the valve 534 is in the closed position, and thevalve 532 is in the open position. During the preliminary phase, thesecond pump 510 may transfer fluid from the fluid reservoir 502 to theflexible fluid container 513, which causes the flexible fluid container513 to expand.

Referring to FIG. 5B, in a first phase of the inflation cycle, thecontroller may move the valve 534 from the closed position to the openposition, and move the valve 532 from the open position to the closedposition. In the first phase of the inflation cycle, the first pump 508and/or the second pump 510 may transfer fluid from the fluid reservoir502 to the inflatable cylinders 504. Referring to FIG. 5C, in a secondphase (e.g., the last part and/or the high pressure part) of theinflation cycle, the controller may cause the valve 532 to transition tothe open position, and the valve 534 remains in the open position. Inthe second phase, when the valve 532 transitions to the open position,fluid from the flexible fluid container 513 is transferred to theinflatable cylinders 504 causing the flexible fluid container 513 tocontract.

FIG. 6 schematically illustrates an inflatable penile prosthesis 600having a pump assembly 606 according to an aspect. The pump assembly 606may include any of the features of the pump assembly (e.g., 106, 306,406, 506) described with reference to the previous figures. The penileprosthesis 600 may include a pair of inflatable cylinders 610, and theinflatable cylinders 610 are configured to be implanted in a penis. Forexample, one of the inflatable cylinders 610 may be disposed on one sideof the penis, and the other inflatable cylinder 610 may be disposed onthe other side of the penis. Each inflatable cylinder 610 may include afirst end portion 624, a cavity or inflation chamber 622, and a secondend portion 628 having a rear tip 632.

The pump assembly 606 may be implanted into the patient's scrotum. Apair of conduit connectors 605 may attach the pump assembly 606 to theinflatable cylinders 610 such that the pump assembly 606 is in fluidcommunication with the inflatable cylinders 610. Also, the pump assembly606 may be in fluid communication with a fluid reservoir 650 via aconduit connector 603. The fluid reservoir 650 may be implanted into theuser's abdomen. The inflation chamber or portion 622 of the inflatablecylinder 610 may be disposed within the penis. The first end portion 624of the inflatable cylinder 610 may be at least partially disposed withinthe crown portion of the penis. The second end portion 628 may beimplanted into the patient's pubic region PR with the rear tip 632proximate the pubic bone PB.

In order to implant the inflatable cylinders 610, the surgeon firstprepares the patient. The surgeon often makes an incision in thepenoscrotal region, e.g., where the base of the penis meets with the topof the scrotum. From the penoscrotal incision, the surgeon may dilatethe patient's corpus cavernosae to prepare the patient to receive theinflatable cylinders 610. The corpus cavernosum is one of two parallelcolumns of erectile tissue forming the dorsal part of the body of thepenis, e.g., two slender columns that extend substantially the length ofthe penis. The surgeon will also dilate two regions of the pubic area toprepare the patient to receive the second end portion 628. The surgeonmay measure the length of the corpora cavernosae from the incision andthe dilated region of the pubic area to determine an appropriate size ofthe inflatable cylinders 610 to implant.

After the patient is prepared, the penile prosthesis 600 is implantedinto the patient. The tip of the first end portion 624 of eachinflatable cylinder 610 may be attached to a suture. The other end ofthe suture may be attached to a needle member (e.g., Keith needle). Theneedle member is inserted into the incision and into the dilated corpuscavernosum. The needle member is then forced through the crown of thepenis. The surgeon tugs on the suture to pull the inflatable cylinder610 into the corpus cavernosum. This is done for each inflatablecylinder 610 of the pair. Once the inflation chamber 622 is in place,the surgeon may remove the suture from the tip. The surgeon then insertsthe second end portion 628. The surgeon inserts the rear end of theinflatable cylinder 610 into the incision and forces the second endportion 628 toward the pubic bone PB until each inflatable cylinder 610is in place.

A pump bulb 631 of the pump assembly 606 may be squeezed or depressed bythe user in order to facilitate the transfer of fluid from the fluidreservoir 650 to the inflatable cylinders 610. For example, in theinflation mode, while the user is operating the pump bulb 631, the pumpbulb 631 may receive the fluid from the fluid reservoir 650, and thenoutput the fluid to the inflatable cylinders 610. When the user switchesto the deflation mode, at least some of the fluid can automatically betransferred back to the fluid reservoir 650 (due to the difference inpressure from the inflatable cylinders 610 to the fluid reservoir 650).Then, the user may squeeze the inflatable cylinders 610 to facilitatethe further transfer of fluid through the pump bulb 631 to the fluidreservoir 650.

FIG. 7 illustrates a flow chart 700 depicting example operations of amethod of inflating an inflatable member of a penile prosthesis. Theexample operations of the flow chart 700 may be performed by any of thepump assemblies (e.g., 106, 306, 406, 506, 606) discussed herein.

Operation 702 includes transferring, by a first pump of a pump assembly,fluid from a fluid reservoir to the inflatable member during a firstphase of an inflation cycle. Operation 704 includes detecting, by asensor, a pressure level in the inflatable member. Operation 706includes activating, by the controller, a second pump of the pumpassembly in response to the pressure level exceeding a threshold level.Operation 708 includes transferring, by at least the second pump, fluidfrom the fluid reservoir to the inflatable member during a second phaseof the inflation cycle.

In some examples, the second pump is disposed in parallel with the firstpump during the first phase. In some examples, the second pump isdisposed in parallel with the first pump during the second phase. Insome examples, the first pump and the second pump are disposed in aparallel configuration during the first phase, where the method furtherincludes switching to a serial configuration during the second phase.The serial configuration is a configuration in which the first pump isserially disposed with respect to the second pump.

While certain features of the described implementations have beenillustrated as described herein, many modifications, substitutions,changes and equivalents will now occur to those skilled in the art. Itis, therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the scope of theembodiments.

What is claimed is:
 1. An inflatable penile prosthesis comprising: afluid reservoir configured to hold fluid; an inflatable member; and apump assembly configured to transfer the fluid from the fluid reservoirto the inflatable member during an inflation cycle, the pump assemblyincluding: a first pump configured to inject the fluid into theinflatable member according to a first flow rate; and a second pumpconfigured to inject fluid into the inflatable member according to asecond flow rate, the second flow rate being less than the first flowrate.
 2. The inflatable penile prosthesis of claim 1, wherein the firstpump includes a plurality of micro-pumps, and the second pump includes aplurality of micro-pumps.
 3. The inflatable penile prosthesis of claim1, wherein the first pump is configured to inject the fluid into theinflatable member up to a first maximum output pressure, and the secondpump is configured to inject the fluid into the inflatable member up toa second maximum output pressure, the second maximum output pressurebeing higher than the first maximum output pressure.
 4. The inflatablepenile prosthesis of claim 1, wherein the second pump is disposed inparallel with the first pump.
 5. The inflatable penile prosthesis ofclaim 1, wherein the pump assembly is configured to move between aparallel configuration in which the second pump is disposed in parallelwith the first pump and a serial configuration in which the second pumpis disposed in serial with the first pump.
 6. The inflatable penileprosthesis of claim 5, further comprising: a controller configured toactuate a plurality of valves to move between the parallel configurationand the serial configuration.
 7. The inflatable penile prosthesis ofclaim 1, further comprising: a controller configured to activate thefirst pump during a first phase of the inflation cycle, the controllerconfigured to activate the second pump during a second phase of theinflation cycle.
 8. The inflatable penile prosthesis of claim 7, whereinthe controller is configured to activate the second pump during thesecond phase of the inflation cycle in response to a pressure level inthe inflatable member exceeding a threshold level.
 9. The inflatablepenile prosthesis of claim 1, wherein the fluid reservoir includes aflexible fluid container disposed within a cavity of the fluidreservoir, the flexible fluid container enclosing fluid at a higherpressure than the fluid contained in the fluid reservoir.
 10. Theinflatable penile prosthesis of claim 9, wherein at least one of thefirst pump or the second pump is configured to transfer the fluid in thefluid reservoir during a first phase of the inflation cycle, the fluidcontained in the flexible fluid container being transferred to theinflatable member during a second phase of the inflation cycle.
 11. Theinflatable penile prosthesis of claim 9, wherein the fluid contained inthe flexible fluid container is transferred to the inflatable memberafter the inflation cycle.
 12. An inflatable penile prosthesiscomprising: a fluid reservoir configured to hold fluid; an inflatablemember; and a pump assembly configured to transfer the fluid from thefluid reservoir to the inflatable member during an inflation cycle, thepump assembly including: a first pump configured to inject the fluidinto the inflatable member; a second pump configured to inject fluidinto the inflatable member; and a controller configured to activate thefirst pump during a first phase of the inflation cycle, the controllerconfigured to activate at least the second pump during a second phase ofthe inflation cycle.
 13. The inflatable penile prosthesis of claim 12,wherein the first pump includes a plurality of micro-pumps disposed on afirst substrate, and the second pump includes a plurality of micro-pumpsdisposed on a second substrate.
 14. The inflatable penile prosthesis ofclaim 13, wherein a number of the plurality of micro-pumps disposed onthe first substrate is less than a number of the plurality ofmicro-pumps disposed on the second substrate.
 15. The inflatable penileprosthesis of claim 12, wherein the first pump is configured to injectthe fluid into the inflatable member according to a first flow rate upto a first maximum output pressure, and the second pump is configured toinject the fluid into the inflatable member according to a second flowrate up to a second maximum output pressure, the first flow rate beinghigher than the second flow rate, the second maximum output pressurebeing higher than the first maximum output pressure.
 16. The inflatablepenile prosthesis of claim 12, wherein the fluid reservoir includes aflexible fluid container disposed within a cavity of the fluidreservoir, the flexible fluid container enclosing fluid at a higherpressure than the fluid contained in the fluid reservoir.
 17. A methodof inflating an inflatable member of a penile prosthesis, the methodcomprising: transferring, by a first pump of a pump assembly, fluid froma fluid reservoir to the inflatable member during a first phase of aninflation cycle; detecting, by a sensor, a pressure level in theinflatable member; activating, by a controller connected to the sensor,a second pump of the pump assembly in response to the pressure levelexceeding a threshold level; and transferring, by at least the secondpump, fluid from the fluid reservoir to the inflatable member during asecond phase of the inflation cycle.
 18. The method of claim 17, whereinthe second pump is disposed in parallel with the first pump during thefirst phase.
 19. The method of claim 17, wherein the second pump isdisposed in parallel with the first pump during the second phase. 20.The method of claim 17, wherein the first pump and the second pump aredisposed in a parallel configuration during the first phase, the methodfurther comprising: switching to a serial configuration during thesecond phase, the serial configuration being a configuration in whichthe first pump is serially disposed with respect to the second pump.